Home NDC 27505-006 ONAPGO
Product NDC 27505-006
11-digit product format 275050006
Labeler code 27505
Product ID 27505-006_4aa2a34c-370f-9da6-e063-6394a90ac79b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Apomorphine hydrochloride
Dosage form INJECTION, SOLUTION
Route SUBCUTANEOUS
Labeler MDD US Operations, LLC, a subsidiary of Supernus Pharmaceuticals, Inc
Application NDA214056
Marketing category NDA
Marketing start 2025-02-04
Substance APOMORPHINE HYDROCHLORIDE
Active strength 4.9 mg/mL
Pharmacologic classes Dopamine Agonists [MoA], Dopaminergic Agonist [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N214056-001 ONAPGO APOMORPHINE HYDROCHLORIDE 98MG/20ML (4.9MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2025-02-03
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N214056-001 NP 2028-02-03
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N214056-001 ONAPGO 98MG/20ML (4.9MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2025-02-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214056-001 ONAPGO 98MG/20ML (4.9MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2025-02-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N214056-001 ONAPGO 98MG/20ML (4.9MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2025-02-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214056-001 ONAPGO 98MG/20ML (4.9MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2025-02-03 fd3edfee7708…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N214056-001 ONAPGO 98MG/20ML (4.9MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2025-02-03 a50c72e98297…
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2026-02-19 14:30 UTC 2026-02 N214056-001 NP 2028-02-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214056-001 NP 2028-02-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N214056-001 NP 2028-02-03 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N214056-001 NP 2028-02-03 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base ONAPGO
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength APOMORPHINE HYDROCHLORIDE 4.9 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination F39049Y068 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2705789 Internal RxNorm lookup 2705796 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 27505-006-01 ONAPGO 20 mL in 1 CARTRIDGE INJECTION, SOLUTION 20 16 27505-006-05 ONAPGO 5 in 1 CARTON INJECTION, SOLUTION 5 16
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 27505-006 ONAPGO (APOMORPHINE HYDROCHLORIDE) INJECTION, SOLUTION [MDD US OPERATIONS, LLC, A SUBSIDIARY OF SUPERNUS PHARMACEUTICALS, INC] 8 Current NDC, 2 package rows 20250328_f3552b6e-5ae7-4993-aa1a-e399c4a7080a.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ONAPGO APOMORPHINE HYDROCHLORIDE MDD US Operations, LLC, a subsidiary of Supernus Pharmaceuticals, Inc f3552b6e-5ae7-4993-aa1a-e399c4a7080a 2026-07-10 Warnings, Adverse reactions Exact identifier application applno (NDA): 214056 application number: NDA214056 ndc (product): 27505-006
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 27505-006-01 27505000601 20 mL in 1 CARTRIDGE 20 ml Historical 27505-006-05 27505000605 5 CARTRIDGE in 1 CARTON (27505-006-05) / 20 mL in 1 CARTRIDGE (27505-006-01) 5 cartridge 2025-02-04 No No Current